Biotronik has announced the positive six-month results from the DELUX registry and 12-month results from the PEPPER study of its Pantera Lux paclitaxel-releasing balloon.
The Pantera Lux paclitaxel-releasing balloon, based on the Pantera semi-compliant balloon, is used to treat restenotic coronary artery lesions after drug-eluting or bare-metal stenting.
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The prospective, multicentre, non-randomised and international DELUX study involved 1,000 patients and showed good safety and efficacy with low revascularisation and myocardial infarction rates.
The 81-patient prospective multicentre non-randomised European first-in-man PEPPER study demonstrated the primary endpoint of in-stent late lumen loss of 0.07mm with effective inhibition of neointimal proliferation in all patients.
